Lipella Pharmaceutical Inc has been successful with development of intravesical liposome for painful bladder syndrome/Interstitial cystitis (PBS/IC). Through SBIR funding, Lipella has been successful in establishing the pre-clinical safety of its primary liposome formulation LPA-08. LPA-08 was discovered at the University of Pittsburgh and exclusively licensed to Lipella. IP of LPA-08 is protected through the filing of two full patent applications. A first patent has already been issued by the USPTO titled Application of Lipid Vehicles and Use for Drug Delivery, patent number 7,063,860, awarded June 20, 2006. This is totally new SBIR-I submission. Lipella will explore the pipeline potential of using intravesical liposome as an advanced intravesical drug delivery platform. Dr. Michael Chancellor was recently recruited from the University of Pittsburgh to become Director of Neurourology Program in the Department of Urology at William Beaumont Hospital in Royal Oak, MI. Dr. Chancellor is also Chairperson of the Scientific Advisory Board (SAB) at Lipella. In this SBIR-I, we will evaluate the 2nd major strength of intravesical liposome as a platform for intravesical drug delivery. This is a new topic for Lipella and is critical for Lipella to be a successful biotechnology company with a product development pipeline. In this six month pilot SBIR-I study, we will evaluate proof of concept of using liquid liposome delivery of botulinum toxin-A (Liposome-BoNT) into the bladder without need for cystscopic guided needle injection for refractory overactive bladder (OAB). If successful, we will leverage commercial investment and SBIR-II on further expanding liposome-BoNT for refractory OAB modeling, delivery of other drugs for OAB and PBS/IC, antibiotics for urinary tract infections and also liposome of chemotherapeutic, and/or immunomodulatory agents for treatment of localized bladder cancer. PUBLIC HEALTH RELEVANCE: Through previous SBIR-I funding, Lipella Pharmaceutical Inc has been successful in establishing the pre-clinical safety of its primary liposome formulation LPA-08. In this completely new SBIR-I submission. Lipella will explore the pipeline potential of using in- travesical liposome as an advanced intravesical drug delivery platform. In this six month pilot SBIR-I study, we will evaluate proof of concept of using liquid liposome delivery of botulinum toxin-A (Liposome-BoNT) into the bladder without need for cystscopic guided needle injection for refractory overactive bladder (OAB).